On October 29, 2024 Foresee Pharmaceuticals Co., Ltd. (TPEx: 6576), ("Foresee") reported that it has submitted a 505(b)(2) New Drug Application for the 3-month version of CAMCEVI, a ready-to-use 3-month depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA) (Press release, Foresee Pharmaceuticals, OCT 29, 2024, View Source [SID1234647503]). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer.

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This NDA submission is supported by a previously successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint.

"Following the successful launch of CAMCEVI 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of CAMCEVI NDA to the U.S. FDA. This marks a significant milestone in our efforts to expand treatment options for patients with advanced prostate cancer. We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026, providing patients with its differentiated ready-to-use profile," said Dr. Ben Chien, Founder and Chairman of Foresee.

On October 28, 2024 Chime Biologics, a leading global CDMO that enables its partners’ success in biologics, reported a strategic collaboration with MedPacto, a South Korean clinically staged company listed on KOSDAQ (235980) (Press release, MedPacto, OCT 28, 2024, View Source [SID1234647457]).

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MedPacto, known for its focus on cancer therapeutics, will leverage Chime Biologics’ expertise in biologics development to streamline the process from tech transfer to cGMP clinical manufacturing for Investigational New Drug (IND) submissions. Under the agreement, Chime Biologics will advance the Chemistry, Manufacturing, and Controls (CMC) process development for the multiple preclinical drug candidates.

Dr. Jungwon Woo, President of MedPacto, stated," We are highly impressed by Chime Biologics’ development and manufacture expertise, which is crucial helping us expand into major global markets. Their ability to meet international standards will greatly support our efforts to advance our assets into a new stage. This collaboration is a key step forward, and we look forward to a successful and long-term partnership."

Dr. Jimmy Wei, President of Chime Biologics, added, "We are pleased to announce our strategic collaboration with MedPacto, a respected KOSDAQ-listed company with a strong portfolio of first-in-class assets. This partnership marks the beginning of a long-term relationship aimed at advancing pharmaceutical innovation. It aligns with our growth strategy in South Korea and aligns with our commitment to the region’s biopharmaceutical landscape. We look forward to working closely with MedPacto and contributing to the success of their innovative pipeline."

Chime Biologics is expanding its manufacturing capacity to 100,000 liters to solidify its position as a leading global CDMO. As part of this strategy, the company is actively entering the South Korean market and has signed agreements with several South Korean biotech companies to provide development and manufacturing services for antibody drugs and biosimilars.

On October 28, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat a range of cancers, infectious diseases, and immune modulated disorders reported that Chief Executive Officer James Passin has been invited to present live at the Emerging Growth Conference on October 30th, 2024 at 9:40 AM EST (Press release, BioVaxys Technology, OCT 28, 2024, View Source [SID1234647458]). This live interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO in real time.

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Please submit your questions in advance to [email protected] or ask your questions during the event.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel, View Source We will release a link to that after the event.

On October 28, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported it will present new data from Cohort B of the TACTI-003 Phase IIb trial in first line recurrent/metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression (CPS <1) at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2024 taking place 11-13 December in Geneva, Switzerland (Press release, Immutep, OCT 28, 2024, View Source [SID1234647441]).

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Presentation details:

Title: TACTI-003 Cohort B: Eftilagimod Alpha (Soluble LAG-3) and Pembrolizumab in FirstLine Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma with CPS <1

Presenter: Martin Forster, M.D., Ph.D., University College London (UCL) Cancer Institute and UCL Hospital NHS Foundation, London, UK

Presentation Number: 152P
Date and Time: Thursday, 12 December 2024 at 12:30 – 13:30PM CET

Abstracts will be made available on the ESMO (Free ESMO Whitepaper) I-O website on 5 December 2024 at 00:05 CET. The poster containing new data, not in the abstract, will be available on the Posters & Publications section of Immutep’s website after its presentation on 12 December 2024.

On October 28, 2024 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE275 (GSK959), a potential first-in-class and best-in-class Werner Helicase (WRN) inhibitor (Press release, Ideaya Biosciences, OCT 28, 2024, View Source [SID1234647459]). IDE275 (GSK959) has demonstrated robust and selective synthetic lethality preclinically in the high microsatellite instability (MSI-High) biomarker setting, and the Phase 1 clinical trial will enroll patients having tumors characterized by MSI-High.

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"IDE275 represents IDEAYA’s fifth potential first-in-class clinical program in our precision medicine oncology pipeline and has a potentially differentiated best-in-class profile that we are targeting to present at a future medical conference with GSK. The robust preclinical efficacy observed by IDE275 selectively in the MSH-High biomarker setting, including monotherapy regressions, provides a double-digit % prevalence target patient population across several major solid tumor types, including endometrial, colorectal and gastric cancer," added Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE275 (GSK959) is a potential first-in-class small molecule inhibitor of Werner Helicase that was discovered by IDEAYA in collaboration with GSK. In preclinical studies, IDE275 has demonstrated robust and selective synthetic lethality in the MSI-High biomarker setting, including single-agent tumor regressions in-vivo in MSI-High CDX and PDX models derived from colorectal, endometrial and gastric cancers. Initiation of the Phase 1 trial for IDE275 is projected in the fourth quarter of 2024. GSK is the sponsor of the IND application and plans to develop IDE275 (GSK959) as both a monotherapy agent and in combination with a PD-1 inhibitor in a Phase 1 clinical trial for patients having MSI-High tumors. The percent prevalence of MSI-High in solid tumors, including endometrial, colorectal, and gastric cancers, has been reported at approximately 31%, 20%, and 19%, respectively (JCO Precision Oncology, September 2017).

GSK is responsible for 80% of global research and development costs for IDE275 (GSK959) and IDEAYA is responsible for 20% of such costs. IDEAYA is eligible to receive a $7 million milestone payment upon acceptance of the IND by the U.S. Food and Drug Administration (FDA), and a potential additional $10 million milestone payment upon initiation of Phase 1 clinical dose expansion. IDEAYA may potentially also receive up to $465 million in further later-stage development and regulatory milestones. Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of IDE275 (GSK959) – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.